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Quality Management Qual 573 الجودة النوعية جود 573 3 (2+1)

Quality Management Qual 573 الجودة النوعية جود 573 3 (2+1). ISO 15189. History. Medical laboratories were becoming more sophisticated: – Automated analysis equipment was being

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Quality Management Qual 573 الجودة النوعية جود 573 3 (2+1)

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  1. Quality Management Qual 573الجودة النوعية جود 5733 (2+1) ISO 15189

  2. History

  3. Medical laboratories were becoming more • sophisticated: – Automated analysis equipment was being • introduced – Quality Control was present but non-standardized – Each European country had its own accreditation • process. – College of American Pathologists were accrediting • laboratories by checklists – Proficiency testing was non-standardized

  4. By 1994… • • Automated equipment was becoming more • reliable, more available. • • College of American Pathologists was accrediting laboratories consistent with American law (CLIA) • • Proficiency Testing was becoming more standardized • • There was a need for a new Quality standard for medical laboratories

  5. International Organization for Standardization • International Organization for Standardization (ISO) announced request for laboratorians to meeting in Philadelphia • to determine if there was interest in development of a new technical committee • to develop a new standard for medical laboratory quality

  6. The new Standard • The creation of a new Quality standard for medical laboratories took 7 years to develop. • Name: Medical Laboratories – Particular • Requirements for Quality and Competence • Number: ISO 15189 • First year Published: 2003 • Revised and Republished: 2007, 2012

  7. The New Standard

  8. Versions • ISO 15189:2012 • ISO 15189:2007 • ISO 15189:2003

  9. ISO 15189:2012 • Medical laboratories -- Requirements for quality and competence

  10. Components • Introduction 1) Object 2) Normative References 3) Terms and definitions 4) Management requirements 5) Technical Requirements Annexes

  11. Components • Introduction • Scope • 2 Normative references • 3 Terms and definitions • 4 Management requirements • 4.1 Organization and Management System • 4.2 Quality Management • 4.3 Document Control • 4.4 Review of Contracts • 4.5 Analysis by reference laboratories • 4.6 External services and supplies • 4.7 Consulting Services 4.8 Resolution Claims • 4.9 Identification and control of non-conformities • 4.10 Corrective action • 4.11 Preventative • 4.12 Continuous Improvement of Quality Registers • 4.13 and technicians • 4.14 Internal audits • 4.15 Management review • 5 Technical Requirements • 5.1 Personal • 5.2 Facilities and environmental conditions of the laboratory • 5.3 Equipment • 5.4 Procedures • 5.5 analytical Pre-Analytical Procedures • 5.6 Assuring the quality of the procedures • 5.7 Process analytical post-analytical • 5.8 Performance Report • Annex A (normative) Correlation with ISO 9001:2000 and ISO / IEC 17025:1999 • Annex B (informative) Information Systems Laboratory (SIL) • Annex C (informative) Ethics in Medicine Laboratory Documents

  12. In UK • United Kingdom Accreditation Service [UKAS] • Clinical Pathology Accreditation [CPA].

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